Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

AEDs, not maternal epilepsy, responsible for birth defects

Posted in Depacon / Depakene / Depakote

Some studies have shown that women with epilepsy have an increased risk for bearing children with major congenital malformations.  And, it has been shown many times that in utero exposure to maternal antiepileptic drugs (AEDs) exacerbates that risk.   The study described below aimed to clarify whether it was maternal epilepsy or in utero exposure to AEDs that was more responsible for birth defects.

Author Fried S. from the University of Toronto, Toronto, Ontario, Canada, wrote an article titled “Malformation Rates in Children of Women With Untreated Epilepsy: A Meta-Analysis”, to determine “if epilepsy per se represents a teratogenic risk”, that is, “To systematically review all studies investigating the occurrence of major malformation rates among children of treated or untreated women with epilepsy and non-exposed controls who do not have epilepsy.”  A random effects model was used for this case-control study, reporting malformations rates in children of women exposed or unexposed to antiepileptic drugs compared to children of nonepileptic mothers.  Author Fried S. claims “We found ten studies reporting results of untreated epilepsy (n = 400) and their non-epileptic healthy controls (n = 2492). Nine out of ten studies also reported results on 1443 patients exposed to antiepileptic drugs and their 2526 unexposed healthy controls. The risk for congenital malformations in the offspring of women with untreated epilepsy was not higher than among nonepileptic controls (odds ratio [OR] = 1.92; 95% CI 0.92-4.00). There was evidence of publication bias, thus with bias removed the OR was 0.99 (95% CI 0.49-2.01).”  The study also showed that children of epileptic mothers who were exposed to AEDs during pregnancy had higher incidences of major congenital malformations.

The above study did not conclude that a women’s epilepsy alone increases the risk of MCMs in her offspring, and suggests that former publications showed bias, which lead to premature conclusions.  Whether or not epilepsy alone puts a child at risk of developing MCMs, the medical world strongly agrees about the risks involved with antiepileptic drugs and their fetus damaging capabilities.  The use of Polytherapy (more than one antiepileptic drug to control seizures) has clearly shown to greatly increase the risk of MCMs, as compared to Monotherapy.  However, Monotherapy may not always be an option depending on how well the patients’ seizures can be controlled.  For many women, the use of 2 or 3 drugs are the only way they can control their epilepsy.

Due to the fact that the manufacturers of some of these drugs have failed to warn women of the risks AEDs pose to their developing babies, AED birth defects lawsuits have been filed around the world.  The chemical most frequently found to be the most dangerous is sodium valproate, the active ingredient in Depacon Depakene, and Depakote.

If you or a loved one used an AED during pregnancy and your child was born with a congenital malformation, you may be entitled to significant financial compensation for the suffering your family has endured.  For more information or a free, no-obligation case consultation, contact our team of  Depacon lawyers at the information provided below.

(855) 452-5529

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.